Novartis flu jab temporarily banned in Italy
The Italian justice authorities are investigating a possible connection between two flu vaccines made by Basel-based pharmaceutical firm Novartis and a small number of unexplained deaths. Although the company says there is no connection, Italy has temporarily banned one of the vaccines.
The Public Prosecutor’s Office in Turin has begun an investigation into the flu vaccine Agrippal, adding to a probe already being conducted into two batches of the vaccine Fluad.
The decision has come after a series of 13 deaths in Italy in people who had been given a flu vaccination.
The Italian Medicines Agency (AIFA) had banned the use of Fluad as a precautionary measure on Thursday.
In a statement on the investigation into Fluad, which has been on the market since 1997, Novartis said that “no causal relationship to the vaccine has been established to date”.
The company added that “worldwide, more than seven million doses of Fluad have been distributed. No unusual frequency of adverse events has been reported through the extensive pharmacovigilance system”.
Italy previously banned the use of some Novartis-made flu vaccines in autumn 2012, including Fluad, after white particles were found in the injections. Other countries, one of which was Switzerland, followed their lead.
After a few weeks however the drug was given the all-clear. The impurity had been found to be clumps of egg white – an ingredient in the vaccine.
The Italian health minister Beatrice Lorenzin said that a connection between the vaccine and the deaths had not been proven.
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